VERBATIM: A randomised controlled trial of aripiprazole for the treatment of auditory verbal hallucinations in borderline personality disorder

Phase 3

Completed

• Conditions: Borderline personality disorder; Auditory verbal hallucinations; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12616001192471
• Lead Sponsor: Orygen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-30
• Study Completion: 2022-09-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

(1) males and females aged 15-25 years inclusive; (2) ability to give informed consent and adhere to study procedures; (3) sufficient fluency in English; (4) Structured Clinical Interview for Diagnostic and Statistical Manual 5th Edition - Personality Disorders (SCID-5-PD) borderline personality disorder; (5) threshold auditory verbal hallucinations (5 or 6 on severity and 4 or more on frequency) for longer than one week within the past four weeks using ratings on the Comprehensive Assessment of At Risk Mental State (CAARMS: Yung et al, 2005).

Exclusion Criteria

(1) DSM-5 schizophreniform disorder, schizophrenia, schizoaffective disorder, psychotic disorder due to another medical condition, catatonia, delusional disorder, bipolar I disorder, or substance/medication induced psychotic disorder; (2) prior sensitivity or allergy to aripiprazole or formulation; (3) antipsychotic treatment for 4 weeks or more at a dose equal to or greater than 200 mg chlorpromazine equivalent within 8 weeks of study entry; (4) pregnancy, lactation, or if sexually active, no effective contraception; (5) clinically significant liver or thyroid function, or haematological findings which in the opinion of the Investigator, may present a safety issue for the participant or confound the trial results; (6) acute or unstable systemic medical disorder; (7) psychiatric condition due to a medical condition; (8) severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol; (9) does not meet the Orygen Youth Health clinical service’s eligibility criteria; (10) for Magnetic Resonance Imaging (MRI) scans: lifetime history of head injury, loss of consciousness for more than 10 mins, seizures, thyroid disorder or other significant medical illness that in the opinion of the Investigator would preclude participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified